Travere

Travere

Quality Associate, Batch Record Review and Product Disposition

San Diego

Sponsorship not specified$10k-$20kDetected 30 days ago
LogisticsProcess ImprovementClinical TrialsGMPMedical DevicesCommunicationCollaborationProblem SolvingMentoringOrganizational SkillsGxP

About the role

  • Participates in supplier meetings, managing production timelines with batch release activities
  • Provides daily oversight of quality systems records including, CAPAs, Deviations, Investigations, Batch Record Review, and Change Controls
  • Provide quality and compliance oversight and act as a SME for the Quality Systems at Travere including, but not limited to:

Responsibilities

  • Support Quality Assurance (QA) Batch Record Review, Product Disposition, and QA Supplier Management including associated quality record management for small molecule, biologics, and device products
  • Collaborate closely with Technical Operations and Clinical Operations Personnel responsible for Manufacturing, Labeling, Packaging, Batch Kitting, and Distribution
  • Manage assigned SOPs revisions and quality records (CAPAs, Deviations, Investigations, Product Complaints, Audit Responses, Change Controls, & Trainings) to ensure timely completion for the organization and associated department(s)
  • Support products for clinical development and commercial production including Oral Drugs, Biologics, and Combination Products
  • Support revision of the existing SOP(s) and Work Instructions related to assigned duties to help define a clear and accurate process
  • Support audit program activities for internal, external, mock, and regulatory audits
  • Document Management

Requirements

  • Minimum of 2-3 years of experience in QA batch record review and leading QA oversight of Contract Manufacturing Organizations (CMOs)
  • The ideal candidate will embody Travere's core values: Patient Inspired, Promoting Community, Courageous, and Stronger Together
  • Prefer but not required: Previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, implement improvements, and respond to situations affecting staff
  • Support QA Supplier Management and Oversight of Contract Manufacturing Organizations (CMOs) starting with Phase 2 Clinical Trials through marketed products, and in all situations where GMP Batches are required

Nice to have

  • Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
  • Quality Assurance (QA) experience with Manufacturing, Laboratories, Logistics, CMOs, Distributors, and Warehouses is preferred

Skills

  • Additional Skills/Experience:

Compensation

  • Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
  • Target Base Pay Range:
  • $85,000.00 - $105,000.00
  • This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Benefits

  • Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
  • Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location.

Equal opportunity

  • If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com.
  • Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only.
  • Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer.
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This listing is sourced directly from Travere's careers page and normalized into a canonical job model.